Various cardiovascular procedures, such as angioplasty and stent placement among others, are performed by inserting into and manipulating within the vasculature, wires and catheters adapted to perform those procedures. In coronary vessel procedures access to the vasculature typically is through the femoral artery and is percutaneous, involving insertion of a needle and introducer sheath in the region of the groin to form a track through subcutaneous and extravascular tissue and to puncture and create an arteriotomy in the femoral artery. A short guidewire then is advanced through the needle and into the femoral artery. The needle then is removed and a dilator carrying an introducer sheath then is advanced over the guidewire, the track and into the femoral artery. The dilator enlarges the track and widens the puncture in the vessel. With the distal end of the introducer sheath having been advanced into the vessel, the dilator and guidewire are removed leaving the sheath in place. The sheath provides access into the femoral artery, through the arteriotomy, for catheters and other instrumentalities in order to perform the selected procedure.
After the procedure has been completed, the procedural devices are removed and the arteriotomy must be closed. A number of techniques are known to facilitate closure and healing of the arteriotomy. These include application of pressure at the puncture site for a relatively extended length of time, or the use of biological adhesives or plugs adapted to seal the arteriotomy, or the use of staples or clips. Some closure systems include an arrangement to engage the artery to temporarily draw the edges of the arteriotomy together while a final closure device, such as a stapler, sutures, adhesives or other means is used to effect the permanent closure of the arteriotomy. Some of these system result in piercing the vessel wall or other tissue, such as systems described, for example, in U.S. Pat. No. 6,767,356 (Kanner) and U.S. Pat. No. 6,391,048 (Ginn et al.).
It would be desirable to provide an alternate closure system in which the arteriotomy could be patched entirely outside of the vessel without risking the trauma that may result from piercing the tissue and also to avoid any possibility of a closure element projecting into the interior of the lumen of the vessel. The present invention is directed to such an alternate mechanism and technique to cause hemostasis at the arteriotomy.